ADVERSE DRUG REACTION;
ARTICLE;
CASE REPORT;
DRUG SURVEILLANCE PROGRAM;
HEALTH SURVEY;
HOSPITAL ADMISSION;
HUMAN;
INDIVIDUAL CASE SAFETY REPORT;
MEDICAL DOCUMENTATION;
MEDICAL STAFF;
NARRATIVE;
PHYSICAL DISEASE BY BODY FUNCTION;
PNEUMONIA;
PRIORITY JOURNAL;
ADVERSE DRUG REACTION REPORTING SYSTEMS;
DATABASES, FACTUAL;
DRUG TOXICITY;
HUMANS;
MEDICAL RECORDS SYSTEMS, COMPUTERIZED;
PILOT PROJECTS;
QUESTIONNAIRES;
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Geneva: ICH Secretariat Oct [online] [Accessed 2011 Jan 21]
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Clinical safety data management: definitions and standards for expedited reporting E2A. Geneva: ICH Secretariat, 2004, Oct [online]. Available from URL:http:// www.ich.org/products/guidelines/ efficacy/article/efficacyguidelines.html [Accessed 2011 Jan 21].
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Geneva: ICH Secretariat Nov [online] [Accessed 2011 Jan 21]
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Post-approval safety data management: definitions and standards for expedited reporting E2D. Geneva: ICH Secretariat 2003 Nov [online]. Available from URL: http://www.ich.org/products/ guidelines/efficacy/ article/efficacy-guidelines.html [Accessed 2011 Jan 21].
US Department of Health and Human Services, Food and Drug Administration [Accessed 2011 Jan 21]
US Department of Health and Human Services, Food and Drug Administration. Form voluntary reporting (form FDA 3500) [online]. Available from URL: http://www.fda. gov/Safety/MedWatch/HowToReport/DownloadForms/de fault.htm [Accessed 2011 Jan 21].
US Department of Health and Human Services, Food and Drug Administration [Accessed 2011 Jan 21]
US Department of Health and Human Services, Food and Drug Administration. Form mandatory reporting (form FDA 3500A) [online]. Available from URL: http://www. fda.gov/Safety/MedWatch/HowToReport/DownloadForms/ default.htm [Accessed 2011 Jan 21].
Council for International Organizations ofMedical Sciences [online] [Accessed 2011 Jan 21]
Council for International Organizations ofMedical Sciences [online]. Available from URL: http://www.cioms.ch/form/ frame-form.htm [Accessed 2011 Jan 21].
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US Department of Health and Human Services, Food and Drug Administration [Accessed 2011 Jan 21]
US Department of Health and Human Services, Food and Drug Administration. Vaccine Adverse Event Reporting System (VAERS) [online]. Available from URL: https:// vaers.hhs.gov/esub/index [Accessed 2011 Jan 21].
Public Health Agency of Canada [Accessed 2011 Jan 21]
Public Health Agency of Canada. Adverse events following immunization reporting form [online]. Available from URL: http://www.phac-aspc.gc.ca/im/aefi- form-eng.php [Accessed 2011 Jan 21].
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Geneva: ICH Secretariat May [online] [Accessed 2011 Jan 21]
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Revision of the ICH guideline on clinical safety data management data element for transmission of individual safety reports E2B (R2). Geneva: ICH Secretariat, 2005 May [online]. Available from URL: http:// www.ich.org/products/guidelines/efficacy/article/ efficacyguidelines.html [Accessed 2011 Jan 21].
Center for Drug Evaluation and Research, Food and Drug Administration [Accessed 2011 Jan 21]
Center for Drug Evaluation and Research, Food and Drug Administration. The clinical impact of adverse event reporting [online]. Available from URL:http://www.fda. gov/downloads/Safety/MedWatch/UCM168505.pdf [Accessed 2011 Jan 21].
US FDA. Patient profile viewer: notice of pilot project [online]. Available from URL: http://www.federalregister. gov/articles/2001/12/10/01- 30430/patient-profile-viewer-no tice-of-pilot-project [Accessed 2011 Jan 21].
Postmarketing safety surveillance: Issues with data collection for postmarketing pharmacovigilance
Edwards B, Prabhakar U. Postmarketing safety surveillance: issues with data collection for postmarketing pharmacovigilance. Pharm Med 2010; 24 (6): 1-6.
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Geneva: ICH Secretariat Aug [online] [Accessed 2011 Jan 21]
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Pharmaceutical development Q8 (R2). Geneva: ICH Secretariat 2009 Aug [online]. Available from URL: http://www.ich.org/products/guidelines/quality/article/ quality-guidelines.html [Accessed 2011 Jan 21]